Anesthetic Block of the Erector Muscles of the Lumbar Spine to Relieve Acute Lumbar Pain: Pilot Study

This study concerns the treatment of recent lumbago and aims to evaluate the efficacy of an anesthetic block of the erector spinae muscles combining ropivacaine and dexamethasone. This treatment is routinely used in several institutions in France, but has never been the subject of a randomized placebo-controlled study to assess its efficacy at D4 of treatment.

The BLOCLOMB comparative, randomized, double-blind study aims to validate the efficacy, over the first 4 days, of anesthetic blocks of the erector spinae muscles, during recent lumbago, on the pain of muscular contractures.

Study Overview

• Status: Not yet recruiting
• Conditions: Lumbago
• Intervention / Treatment: Drug: Ropivacaine and dexamethasone injection solution; Drug: Sodium Chloride 0.9% Injection Solution

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yves MAUGARS, PhD; Phone Number: +33 6 44 36 04 00; Email: cyhmla@gmail.com
• Study Contact Backup: Name: Vincent WHYART; Email: vincent.wyart@elsan.care

Study Locations

• France
  • St Herblain, France, 44800
    • Santé Atlantique ELSAN
    • Contact: Vincent WHYART; Email: vincent.wyart@elsan.care
    • Contact: Yves MAUGARS, PhD
    • Principal Investigator: Yves MAUGARS, PhD
    • Sub-Investigator: Fabian ROY-GASH, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient with lumbago lasting less than 7 days despite analgesic / NSAID treatment.
2. Patient with NS pain > 6
3. Patient with Oswestry score > or equal to 30
4. Patient informed of the trial and having signed the informed consent form prior to any trial-specific procedure,
5. Patient willing and able to undergo all planned examinations and procedures in compliance with the clinical trial protocol,
6. Patient affiliated to a social security or any health insurance.

Exclusion Criteria:

1. Presence of "red flag" (non-disc lumbago):

   • Motor deficit or signs of horsetail irritation
   • Inflammatory pain waking up in the 2nd half of the night
   • Tumoral context
   • Infectious context or fever
   • Altered general condition
   • Traumatic context
   • Osteoporotic context
2. Risk of infection
3. Patient with poor local skin condition
4. Patient on AVK or anti-Xa anticoagulation, or bleeding disorder (antiaggregants authorized)
5. Patients with hypersensitivity to Ropivacaine or any of its excipients: Sodium chloride, hydrochloric acid sodium hydroxide
6. Patient with sciatica
7. Patient with chronic respiratory insufficiency
8. Patient with cardiac rhythm disorders
9. Pregnant or breastfeeding woman or woman refusing effective contraception
10. Patient deprived of liberty or under legal protection (guardianship or curator)
11. Patient participating in another clinical research protocol involving a drug or medical device
12. Patient unable to follow the protocol, as judged by the investigator
13. Patient refusing to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intravenous injection of Ropivacaine combined with Dexamethasone + usual treatment; The experimental treatment consists in one single interlaminal injection of 2x20ml Ropivacaine (0.375%) distributed over the L4-L5 (Lumbar vertebrae 4 and 5) and L5-S1 (Lumbar vertebrae 5 and sacrum 1) levels on both sides, combined with 2x4ml Dexamethasone soluble (i.e. 2x1ml). This dose and method of administration are those required for locoregional anesthesia.	Drug: Ropivacaine and dexamethasone injection solution; Injection of Ropivacaine and dexamethasone
Placebo Comparator: Intravenous injection of Placebo (sodium chloride 0.9%) + usual treatment; The placebo treatment consists in one single interlaminal injection of 2x20ml sodium chloride 0.9% distributed over the L4-L5 and L5-S1 levels on both sides.	Drug: Sodium Chloride 0.9% Injection Solution; Injection of sodium chloride 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lumbar pain in activity	Area under the curve of lumbar pain in activity measured by the patient on a numeric scale (from 0=no pain, and 10=unbearable pain)	At Hour 0-Hour1-Hour4-Hour8-Hour12 and Day 1-Day2-Day3-Day4. (Hour 0=injection time, Day 1=One day after injection time)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consumption of concomitant lumbago treatments	Recording of analgesics and NSAIDs, physiotherapy, manipulations, open surgery, etc	From Day 0 (day of injection) to Day 4
Lumbar pain at rest	Lumbar pain measured by the patient on a numeric scale	Day 4
Lumbar pain in activity	Lumbar pain measured by the patient on a numeric scale	Day 4
Lumbar pain at rest	Area under the curve of lumbar pain at rest measured by the patient on a numeric scale	At Hour 0-Hour1-Hour4-Hour8-Hour12 and Day 1-Day 2-Day 3-Day 4-Day 7-Day 14-Day 21-Day 28
Lumbar Pain < 3	Percentage of patients with pain < 3 (measured by the patient on a numeric scale, at rest)	Day 4
Algofunctional index	Oswestry questionnaire: comprises 10 questions on pain, personal care, load-bearing, walking, sitting, standing, sleep, sex life, social life and travel. Each question offers 6 answers, with a score from 0 to 6, which the patient must choose; a score of 0 corresponds to normal function, and a score of 6 to severely impaired function. The score obtained is multiplied by 2 to obtain a percentage of disability, with 0% for no disability, and 100% for the greatest disability.	Day 0, Day 4 and Day 28
Duration of the interruption of current activities	Number of days without current activities	28 days
Duration of the interruption of work	Number of days of sick leave	28 days
Complications	Complications will focus on the following adverse events: injection-site hematoma, nerve damage, limb pain, convulsions, respiratory discomfort, bradycardia, severe vagal malaise; fall, iatrogenic infection; new lumbago, sciatica or complicated crural neuralgia (neurological deficit, cauda equina syndrome); allergy, digestive complication, renal complication; other to be specified	28 days

Collaborators and Investigators

• Sponsor: Elsan

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): September 4, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 15, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: pain; anesthetic blocks
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anesthetics, Local; Dexamethasone; Dexamethasone acetate; Pharmaceutical Solutions; Ropivacaine
• Other Study ID Numbers: BLOCLOMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No